Clinical trial Recruiting at 1 site Interventional Ages 18 and up Men only

Focal salvage brachytherapy for recurrent prostate cancer

Official title: Assessment of the Toxicity of Focal Salvage Brachytherapy of Recurrent Prostate Cancer After Prior Radiotherapy - the Prospective Focal Salvage Brachytherapy Study (FocaSaBra)

Run by The Greater Poland Cancer Centre · NCT05715502 · Data updated 2026-11-12

This study is testing a targeted radiation treatment for men with recurring prostate cancer after previous radiation to see if it can help them without harming nearby organs.

More Prostate Cancer trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment100 (estimated)
SponsorThe Greater Poland Cancer Centre
Academic / other
Drugs / interventionsradiation
Locations1 site (Poznan, Greater Poland Voivodeship)
StatusRecruiting
StartedMay 1, 2022
Main results expectedDecember 31, 2025
Study endsDecember 31, 2028
Registry record updatedApril 30, 2025
Trial IDNCT05715502 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include men with histologically confirmed localized recurrence of prostate cancer after prior radical radiotherapy and specific PSA levels.

Probably not a fit

Patients with distant metastases, high PSA levels, or significant comorbidities may not benefit from this treatment.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective phase II study evaluates the safety and toxicity of focal salvage brachytherapy in patients with localized recurrence of prostate cancer after prior radiotherapy. The study aims to treat patients who have experienced local recurrence while ensuring that critical organs are protected from excessive radiation exposure. Patients will undergo imaging assessments to confirm localized tumors and exclude distant metastases before receiving the brachytherapy treatment. The goal is to provide a targeted approach that may improve outcomes for patients with recurrent prostate cancer.

Why it matters

Potential benefit: If successful, this treatment could offer a less toxic and more effective option for patients with recurrent prostate cancer.

How similar studies have gone: Previous studies have shown promise for salvage brachytherapy in similar patient populations, indicating potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Histopathologically confirmed by biopsy (fusion mapping biopsy preferred) recurrence of prostate cancer after prior radical radiotherapy (brachytherapy, external beam radiotherapy alone or with brachytherapy boost, stereotaxic radiotherapy)
* Localized tumor lesion assessed by MRI or in the case of MR contraindications with TRUS and CT
* Exclusion of distant metastases using CT, MR, or PET imaging
* PSA doubling time over six months
* PSA value \<10 ng / ml
* No anti-androgen treatment in the year prior
* Dysuria on the IPSS (International Prostate Symptom Score) ≤ 20 points
* General condition according to the WHO scale ≤ 2
* Signing informed consent to participate in the study

Exclusion Criteria:

* PSA value\> 10ng / ml
* General condition according to the WHO scale\> 2
* Dysuria on the IPSS scale\> 20 points
* PSA doubling time \<6 months
* Inability to discontinue anticoagulants.
* An active urinary tract infection.
* Contraindications to general anesthesia
* Active inflammatory bowel diseases.
* Second active cancer or treatment with completion less than 3 years earlier, except for low-stage skin cancer
* Estimated Survival \<5 years

Where it's running

  • Greater Poland Cancer Centre / Brachytherapy Department
    Poznan, Greater Poland Voivodeship, Poland
    Recruiting

Study contacts

  • Principal investigator: Wojciech Burchardt, PhD, MD — Greater Poland Cancer Centre / Brachytherapy Department
  • Study coordinator: Wojciech Burchardt, PhD, MD
  • Email: wojciech.burchardt@wco.pl
  • Phone: +48505149659

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.